Fibromyalgia generally is understood as a condition including widespread chronic muscle pain, fatigue, and abnormal sleep patterns. See, e.g., Wolfe et al., "The Fibromyalgia Syndrome: A Consensus Report on Fibromyalgia and Disability", The Journal of Rheumatology, 23(3):534-539 (1996). It afflicts perhaps 2% of the population of the United States. Fibromyalgia varies in its effects on those who suffer from it, but in severe cases, it is completely debilitating. Fibromyalgia is closely related to chronic fatigue and irritable bowel syndromes, and some believe that these are all just different facets of the same underlying disorder. Women are 10 to 20 times more likely to get fibromyalgia than men.
Fibromyalgia signs and symptoms include: widespread pain (97.6% of the patients), tenderness in &gt;11/18 "tender points" (90.1%), fatigue (81.4%), morning stiffness (77.0%), sleep disturbance (74.6%), parethesias (62.8%), headache (52.8%), anxiety (47.8%), dysmenorrhea (40.6%), sicca symptoms (35.8%), depression (31.5%), irritable bowel syndrome (29.6%), urinary urgency (26.3%), and Raynaud's phenomenon (16.7%).
The cause of fibromyalgia is unknown and it is difficult to diagnose accurately. Sufferers have been especially distressed by health service providers and researchers who claim the condition is psychosomatic. The disease is associated with a lack of restful sleep, although researchers have not been able to establish whether this insomnia is a cause or an effect of fibromyalgia.
No known cure exists for fibromyalgia, and elimination of the symptoms is difficult. Some help has been realized by treating those suffering with the disease with antidepressants, analgesics, gentle and controlled exercise, counseling and education, and life-style changes. Since no single one of these therapies or any combination of them has been shown to give general relief, the search continues for some treatment which will help fibromyalgia sufferers to ameliorate their symptoms. Drug treatments which have been tried include: trazodone, diphenhydramine, cyclobenzaprine, alprazolam, carisoprodol, 5-hydroxytryptophan, and amitriptyline. Pharmaceutically effective amounts of these compounds are well-known to those of skill in the art. Dietary supplements reported to reduce the symptoms of fibromyalgia include proanthocyanins, blue-green algae, malic acid and magnesium salts. It is unknown whether any of these are effective, although their usually administered dosages (which are to be considered "pharmaceutically effective amounts" for use herein) are known to those of skill in the art.
It would be a significant improvement in the art to have a treatment effective in ameliorating the symptoms of fibromyalgia syndrome (i.e., fibromyalgia, chronic fatigue syndrome and irritable bowel syndrome) or to prevent their occurrence in the first place.
1H-indole-3-methanol (CAS Registry Number 700-06-1!) is a naturally occurring product which is derived from cruciferous vegetables. It is known to exhibit substantial effects in the metabolism of estradiol as reported by many workers, and has been implicated as having potential utility in the treatment of breast cancer. In this regard, one of 1H-indole-3-methanol's pharmacological activities is that of an estradiol 2-hydroxylase inducer. Some of its effects have been summarized in a review by Michnovicz and co-workers. Michnovicz et al. "Changes in Levels of Urinary Estrogen Metabolites After Oral Indole-3-Carbinol Treatment in Humans", J. Nat'l Cancer Inst., 89(10):718-23 (1997). It has also been observed that 1H-indole-3-methanol reacts with itself in stomach acid and under other conditions such as heat, light and even plain water solutions to form new compounds ("1H-indole-3-methanol compounds"). See, e.g., Michnovicz & Bradlow, "Dietary Cytochrome P-450 Modifiers in the Control of Estrogen Metabolism", Food Phytochemicals or Cancer Prevention I, Fruits & Vegetables, pp. 282-293, nn. 89-93, edited by Mou-Tuan et al. ACS Symposium Series 546 (American Chemical Society, Washington, D.C., 1994). Some of these 1H-indole-3-methanol compounds (e.g., diindolylmethane and indolo(3,2-b)carbazole) are reported to bind the same receptors as the 1H-indole-3-methanol. Id.
Although described for the potential treatment of breast cancer, heretofore the use of 1H-indole-3-methanol compounds for treating conditions such as fibromyalgia syndrome is not believed to have been described.